BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2936030 · Received January 30, 2013

    Report

    Report Number
    2024168-2013-00486
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DATE OF EVENT ESTIMATED AS (B)(6)2013. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE PART AND LOT NUMBERS WERE NOT REPORTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN MADE A GENERAL COMMENT THAT DURING USE WITH THE TREK BALLOON CATHETERS AND THE NC TREK BALLOON CATHETERS, THE DEVICES SLIPPED OUT OF THE LESION DURING INFLATION (WATERMELON-SEEDING). THIS OCCURRED AT AN AVERAGE OF 8 ATMOSPHERES OR HIGHER. IN ALL CASES THE BALLOON WAS JUST DEFLATED AND AGAIN PLACED IN THE LESION. THE LESION WAS THEN DILATED SUCCESSFULLY WITH THE SAME DEVICE. THE BALLOONS WERE PREPARED PER THE INSTRUCTIONS FOR USE, PRIOR TO USE IN THE PATIENT AND THERE WAS NO RESISTANCE NOTED DURING REMOVAL OF THE SHEATH. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40327 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1